Rivaroxaban synoptis

Package leaflet: Information for the patient

Rivaroxaban Synoptis, 15 mg, coated tablets
Rivaroxaban Synoptis, 20 mg, coated tablets
Rivaroxabanum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Rivaroxaban Synoptis is and what it is used for
2. Important information before taking Rivaroxaban Synoptis
3. How to take Rivaroxaban Synoptis
4. Possible side effects
5. How to store Rivaroxaban Synoptis
6. Contents of the pack and other information

1. What Rivaroxaban Synoptis is and what it is used for

Rivaroxaban Synoptis contains the active substance rivaroxaban.
Rivaroxaban Synoptis is used in adults to:

• prevent the formation of blood clots in the brain (stroke) and other blood vessels in the body in patients with a type of irregular heartbeat called non-valvular atrial fibrillation.
• treat blood clots in the veins of the legs (deep vein thrombosis) and blood vessels of the lungs (pulmonary embolism), and to prevent recurrence of blood clots in the veins of the legs and/or lungs.

Rivaroxaban Synoptis is used in children and adolescents under 18 years of age and weighing 30 kg or more to:

• treat blood clots and prevent recurrence of blood clots in the veins or blood vessels of the lungs, after at least 5 days of initial treatment with injectable anticoagulant medicines.

Rivaroxaban Synoptis belongs to a group of medicines called anticoagulants. It works by blocking a blood clotting factor (factor Xa), thereby reducing the tendency for blood clots to form.

2. Information before taking Rivaroxaban Synoptis

When not to take Rivaroxaban Synoptis

• if the patient is allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6),
• if the patient is experiencing excessive bleeding,
• if the patient has a disease or condition of an organ that leads to an increased risk of serious bleeding (e.g. stomach ulcer, trauma or bleeding into the brain, recent surgery on the brain or eyes),
• if the patient is taking other anticoagulant medicines (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or if heparin is administered to maintain the patency of a catheter in a vein or artery,
• if the patient has a liver disease that leads to an increased risk of bleeding,
• if the patient is pregnant or breastfeeding.

Do not use Rivaroxaban Synoptis and inform your doctor if
you suspect that any of the above conditions apply to you.
Warnings and precautions
Before starting Rivaroxaban Synoptis, consult your doctor or
pharmacist.
When to exercise special caution with Rivaroxaban Synoptis

• if the patient has an increased risk of bleeding, such as in the following conditions:
• severe kidney disease in adults, and moderate or severe kidney disease in children and adolescents, because kidney function may affect the amount of medicine acting in the patient's body,
• blood clotting disorders,
• taking other anticoagulant medicines (e.g. warfarin, etexilate dabigatran, apixaban or heparin) when switching anticoagulant therapy or when heparin is administered to maintain the patency of a catheter in a vein or artery (see section “Rivaroxaban Synoptis with other medicines”),
• very high blood pressure that does not decrease despite medication,
• diseases of the stomach or intestines that may cause bleeding, e.g. inflammation of the intestines and stomach or oesophagitis (throat and oesophagus), e.g. due to gastroesophageal reflux disease (backflow of stomach acid into the oesophagus) or tumours located in the stomach or intestines or in the genital or urinary system,
• blood vessel disease of the back of the eye (retinopathy),
• lung disease in which bronchi are dilated and filled with pus (bronchiectasis) or previous lung bleeding,
• in patients with prosthetic heart valves,
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing increased risk of blood clots), the patient should inform the doctor, who will decide whether treatment should be changed,
• if the patient has abnormal blood pressure or is scheduled for surgery or other treatment aimed at removing a pulmonary embolism.

If you suspect that any of the above conditions apply to you, inform your doctor
before taking Rivaroxaban Synoptis. The doctor will decide whether to use this medicine
and whether the patient requires particularly close monitoring.
If the patient needs surgery

• strictly follow the doctor's instructions regarding the timing of taking Rivaroxaban Synoptis before or after surgery,
• if catheterisation or spinal puncture (e.g. for epidural or intrathecal anaesthesia or pain relief) is planned during surgery:
• it is very important to take Rivaroxaban Synoptis before and after the puncture or catheter removal as directed by the doctor,
• inform the doctor immediately if numbness or weakness in the legs, or bowel or bladder dysfunction occurs after the end of anaesthesia, as immediate treatment may be necessary.

Children and adolescents
Rivaroxaban Synoptis is not recommended for children weighing less than 30 kg.
There is insufficient data on the use of rivaroxaban in children and adolescents for adult indications.
Rivaroxaban Synoptis with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.

• If you are taking
• certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only topically on the skin,
• ketoconazole tablets (used in the treatment of Cushing's syndrome, in which the body produces too much cortisol),
• certain antibiotics (e.g. clarithromycin, erythromycin),
• certain antiviral medicines used in HIV infection or AIDS treatment (e.g. ritonavir),
• other medicines used to reduce blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists such as warfarin or acenocoumarol),
• anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid),
• dronedarone, a medicine used to treat heart rhythm disorders,
• certain medicines used to treat depression (selective serotonin reuptake inhibitors (SSRI) or serotonin-noradrenaline reuptake inhibitors (SNRI)).

If you suspect that any of the above conditions apply to you, inform your doctor
before taking Rivaroxaban Synoptis, as the effect of Rivaroxaban Synoptis may be enhanced when taken together with the above-mentioned medicines. The doctor will decide whether to use this medicine and whether the patient requires particularly close monitoring.
If the doctor considers that the patient has an increased risk of developing gastric or duodenal ulcers, he may prescribe treatment to prevent peptic ulcer disease.

• If you are taking
• certain medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital),
• St John's wort (Hypericum perforatum), a herbal remedy used for depression,
• rifampicin, which belongs to the group of antibiotics.

If you suspect that any of the above conditions apply to you, inform your doctor
before taking Rivaroxaban Synoptis, as the effect of Rivaroxaban Synoptis may be reduced when taken together with the above-mentioned medicines. The doctor will decide whether to use Rivaroxaban Synoptis and whether the patient requires particularly close monitoring.
Pregnancy and breastfeeding
Do not use Rivaroxaban Synoptis if you are pregnant or breastfeeding. If there is a risk that you may become pregnant, you should use an effective method of contraception during treatment with Rivaroxaban Synoptis. If you become pregnant while taking Rivaroxaban Synoptis, inform your doctor immediately, who will decide on further treatment.
Driving and operating machinery
Rivaroxaban Synoptis may cause dizziness (common side effects) and fainting (uncommon side effects) (see section 4 “Possible side effects”).
Patients experiencing these side effects should not drive, ride a bicycle, or operate tools or machinery.
Rivaroxaban Synoptis contains lactose monohydrate and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult the doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered “sodium-free”.

3. How to take Rivaroxaban Synoptis

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Rivaroxaban Synoptis should be taken with food.
The tablet(s) should be swallowed whole, preferably with water.
If a patient has difficulty swallowing the whole tablet, discuss alternative methods of taking Rivaroxaban Synoptis with the doctor. The tablet may be crushed and mixed with water or soft food such as apple puree immediately before administration. After consuming this mixture, a meal should be taken promptly.
If necessary, a doctor may administer crushed Rivaroxaban Synoptis tablets via a gastric tube.

How many tablets to take

• Adults
• For prevention of blood clots in the brain (stroke) and other blood vessels in the body: The recommended dose is one Rivaroxaban Synoptis 20 mg tablet once daily. If the patient has kidney problems, the dose may be reduced to one Rivaroxaban Synoptis 15 mg tablet once daily.

If a patient requires a procedure to open blocked blood vessels in the heart (called percutaneous coronary intervention – PCI with stent placement), there is limited evidence supporting dose reduction to one Rivaroxaban Synoptis 15 mg tablet once daily (or one 10 mg rivaroxaban tablet once daily if renal impairment is present), in combination with an antiplatelet medicine such as clopidogrel.

• For treatment of blood clots in the leg veins, blood clots in the blood vessels of the lungs, and prevention of recurrence of blood clots: The recommended dose is one Rivaroxaban Synoptis 15 mg tablet twice daily for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one Rivaroxaban Synoptis 20 mg tablet once daily. After at least 6 months of treatment for blood clots, the doctor may decide to continue treatment with either one tablet containing 10 mg rivaroxaban once daily or one Rivaroxaban Synoptis 20 mg tablet once daily. If the patient has kidney disease and is taking one Rivaroxaban Synoptis 20 mg tablet once daily, the doctor may decide to reduce the dose after 3 weeks of treatment to one Rivaroxaban Synoptis 15 mg tablet once daily, if the risk of bleeding is greater than the risk of further blood clots.

• Children and adolescents The dose of Rivaroxaban Synoptis depends on body weight and will be calculated by the doctor.

• The recommended dose for children and adolescents with a body weight of 30 kg to less than 50 kg is one Rivaroxaban Synoptis 15 mg tablet once daily.

• The recommended dose for children and adolescents with a body weight of 50 kg or more is one Rivaroxaban Synoptis 20 mg tablet once daily.

Each dose of Rivaroxaban Synoptis should be taken with a meal and with a drink (e.g. water or juice). Tablets should be taken every day at approximately the same time. Consider setting an alarm to remind you.
For parents or caregivers: observe the child to ensure the full dose has been taken.
The dose of Rivaroxaban Synoptis is based on body weight, so it is important to attend scheduled doctor’s appointments, as dose adjustments may be needed due to changes in body weight.
Never adjust the dose on your own. If necessary, the doctor will adjust the dose.
Do not split the tablet to achieve a partial dose. If a lower dose is required, a different formulation of the medicine should be used, such as granules for oral suspension.
For children and adolescents who cannot swallow whole tablets, rivaroxaban in the form of granules for oral suspension should be used.
If the oral suspension is not available, the Rivaroxaban Synoptis tablet may be crushed and mixed with water or apple puree immediately before administration. After consuming this mixture, a meal should be taken. If necessary, the doctor may also administer the crushed tablet via a gastric tube.

If a dose is vomited or spat out

• Within 30 minutes of taking Rivaroxaban Synoptis, take a new dose.
• More than 30 minutes after taking Rivaroxaban Synoptis, do not take another dose. In this case, take the next dose at the usual time.

Contact your doctor if multiple doses are repeatedly vomited or spat out after taking Rivaroxaban Synoptis.

When to take Rivaroxaban Synoptis
Take the tablet(s) every day until your doctor decides to stop treatment.
It is best to take the tablet(s) at the same time each day, as this makes it easier to remember.
Your doctor will decide how long treatment should continue.
Prevention of blood clots in the brain (stroke) and other blood vessels in the body:
If a procedure to restore normal heart rhythm (cardioversion) is required, Rivaroxaban Synoptis should be taken as directed by your doctor.

Missed dose of Rivaroxaban Synoptis

• Adults, children and adolescents: If the patient takes one 20 mg tablet or one 15 mg tablet once daily and a dose is missed, take the tablet as soon as possible. Do not take more than one tablet in one day to make up for a missed dose. Take the next tablet the following day, then continue taking one tablet once daily.
• Adults: If the patient takes one 15 mg tablet twice daily and a dose is missed, take the tablet as soon as possible. Do not take more than two 15 mg tablets in one day. If a dose was forgotten, the patient may take two 15 mg tablets at the same time to achieve a total of two tablets (30 mg) taken within one day. The next day, continue taking one 15 mg tablet twice daily.

Taking more Rivaroxaban Synoptis than prescribed
If a patient takes more Rivaroxaban Synoptis than prescribed, contact a doctor immediately. Taking too high a dose of Rivaroxaban Synoptis increases the risk of bleeding.

Stopping Rivaroxaban Synoptis
Do not stop taking Rivaroxaban Synoptis without first consulting your doctor, as Rivaroxaban Synoptis treats and prevents serious medical conditions.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
As with other medicines with a similar mechanism of action that reduce blood clot formation,
Rivaroxaban Synoptis may cause bleeding, which potentially could be life-threatening.
Excessive bleeding may lead to a sudden drop in blood pressure (shock). Signs of bleeding are not always obvious or visible.
You should immediately inform your doctor if any of the following adverse reactions occur:

• Signs of bleeding
• bleeding into the brain or inside the skull (symptoms may include headache, one-sided paralysis, vomiting, seizures, decreased level of consciousness, and neck stiffness. A severe, sudden medical emergency. Immediate medical assistance must be sought!),
• prolonged or excessive bleeding,
• unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina. Your doctor may decide that close monitoring of the patient or a change in treatment is necessary.
• Signs of severe skin reactions
• widespread, acute skin rash, blistering or mucosal lesions, e.g. in the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• drug reaction causing rash, fever, internal organ inflammation, hematological disorders and systemic symptoms (DRESS syndrome). The frequency of these adverse reactions is very rare (occurring in up to 1 in 10,000 people).
• Signs of severe allergic reactions
• swelling of the face, lips, oral cavity, tongue or throat; urticaria and breathing difficulties; sudden drop in blood pressure. The frequency of severe allergic reactions is very rare (anaphylactic reactions, including anaphylactic shock, may occur in up to 1 in 10,000 people) and uncommon (angioedema and allergic edema may occur in 1 in 100 people).

General list of possible adverse reactions in adults, children and adolescents:

• Common (may occur in 1 in 10 patients)
• decrease in red blood cell count, which may cause paleness of the skin and lead to weakness or shortness of breath,
• gastrointestinal or intestinal bleeding, bleeding from the urogenital system (including blood in urine and heavy menstrual bleeding), nosebleeds, gum bleeding,
• bleeding into the eye (including conjunctival hemorrhage),
• bleeding into tissues or body cavities (hematoma, bruising),
• presence of blood in sputum (hemoptysis) during coughing,
• skin bleeding or subcutaneous bleeding,
• postoperative bleeding,
• oozing of blood or fluid from surgical wound,
• limb swelling,
• limb pain,
• kidney function disorders (may be observed in tests performed by a doctor),
• fever,
• stomach pain, indigestion, nausea or vomiting, constipation, diarrhea,
• low blood pressure (symptoms may include dizziness or fainting upon standing),
• general decrease in strength and energy (weakness, fatigue), headache, dizziness,
• rash, skin itching,
• increased activity of certain liver enzymes, which may be evident in blood test results.

Uncommon (may occur in 1 in 100 patients)

• bleeding into the brain or inside the skull (see above signs of bleeding),
• joint bleeding causing pain and swelling,
• thrombocytopenia (low platelet count, cells involved in blood clotting),
• allergic reactions, including allergic skin reactions,
• liver function disorders (may be observed in tests performed by a doctor),
• blood tests may show increased levels of bilirubin, increased activity of certain pancreatic or liver enzymes, or increased platelet count,
• fainting,
• malaise,
• rapid heartbeat,
• dry mouth,
• urticaria.

Rare (may occur in 1 in 1000 patients)

• muscle bleeding,
• cholestasis (bile stasis), hepatitis including liver cell damage,
• yellowing of the skin and eyes (jaundice),
• local swelling,
• blood collection (hematoma) in the groin as a complication of cardiac catheterization when the catheter is inserted into an artery in the leg (pseudoaneurysm).

Frequency not known (frequency cannot be estimated from available data)

• kidney failure following severe bleeding,
• increased pressure in the muscles of arms and legs occurring after bleeding, which may lead to pain, swelling, altered sensation, numbness or paralysis (compartment syndrome following bleeding).

Adverse reactions in children and adolescents
In general, adverse reactions observed in children and adolescents treated with rivaroxaban
were similar in type to those observed in adults and were mostly mild to moderate in severity.
Adverse reactions observed more frequently in children and adolescents:
Very common (may occur in more than 1 in 10 patients)

• headache,
• fever,
• nosebleeds, vomiting.

Common (may occur in 1 in 10 patients)

• rapid heartbeat,
• blood test results may show increased bilirubin levels (a bile pigment),
• thrombocytopenia (low platelet count, cells that help in blood clotting),
• excessive menstrual bleeding.

Uncommon (may occur in 1 in 100 patients)

• blood test results may show increased levels of a subcategory of bilirubin (direct bilirubin, a bile pigment).

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed
in this leaflet, you should inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Rivaroxaban Synoptis

Keep this medicine out of the sight and reach of children.
No special storage conditions apply for this medicine.
Crushed tablets are stable in water or apple puree for up to 4 hours.
Do not use this medicine after the expiry date stated on the carton and blister marked as EXP.
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Rivaroxaban Synoptis contains

• The active substance is rivaroxaban. Each coated tablet contains 15 mg or 20 mg of rivaroxaban.
• Other ingredients are:
  Tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, hypromellose, sodium lauryl sulfate, magnesium stearate.
  Coating: hypromellose 2910, titanium dioxide (E 171), macrogol 4000, iron oxide red (E172).

What Rivaroxaban Synoptis looks like and contents of the pack
Rivaroxaban Synoptis 15 mg: red, round, biconvex coated tablets with the engraved mark "15" on one side and smooth on the other side.
Rivaroxaban Synoptis 20 mg: brown-red, round, biconvex coated tablets with the engraved mark "20" on one side and smooth on the other side.
Coated tablets are available in PVC/PCTFE/aluminum blister packs contained in a cardboard box.
Pack sizes: 14, 28, 42 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw
Poland

Manufacturer
Chanelle Medical Unlimited Company
Dublin Road, Loughrea
Co. Galway, H62 FH90
Ireland

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Synoptis Pharma Sp. z o.o.
tel. +48 22 32 16 240